Ambulatory ECMO System

Ension，Inc.开发了一种非常有效的主动混合膜氧合器（AMMO），具有在输送气体时泵送血液的固有能力。 目前，该装置由0.5 m2的膜表面积和泵送6.0 Lpm的血液组成。Envsion建议改变其目前的急性使用AMMO设计，以满足需要长期肺支持的成人患者的需求。目前，这些患者与重症监护室有关，在那里他们被保持镇静，以通过防止运动来最大限度地减少他们的氧气需求。拟议的移动式ECMO系统（M-AMMO，"M"=移动性）将在我们非常有效的泵-氧合器盘配置和静脉-静脉插管中采用涂层光纤。增加的M-AMMO系统效率将允许比目前可用的更大的气体传输速率，并且将足够紧凑以允许患者从ICU转移。此外，如果M-AMMO按设计运行，则可以减少或排除对机械通气的需要及其伴随的发病率。这个第一阶段计划旨在证明我们的概念的可行性。本项目的目的是修改我们目前的设计，以满足需要长期呼吸支持的成年患者的需求，进行充分的体外和体内试验，以评价系统性能和预期用途的适用性，并开发一个原型手动控制器。如果成功的话，我们相信这种Ension产品将获得整个医学界心胸外科医生和肺病学家的认可。拟议的商业应用：每年大约有100例成人ECMO应用自愿报告给ELSO登记处，还有更多的未报告。一种能够为非卧床患者提供所有呼吸支持的设备可以提供机械通气的一个重要替代方案，通过允许患者转移到"降压"单元来降低总体成本，并成为人工肺的先驱。

Ension, Inc. has developed a very efficient Active Mixing Membrane Oxygenator (AMMO) with an inherent ability to pump blood as it transfers gases. Currently, this device consists of 0.5 m2 of membrane surface area and pumps 6.0 Lpm of blood. Envsion is proposing to alter its current acute-use AMMO design to meet the needs of adult-sized patients who require long-term pulmonary support. Currently, these patients are related to the intensive care unit where they are kept sedated to minimize their oxygen requirements by preventing movement. The proposed Ambulatory ECMO System (M-AMMO, "M"=mobility) will employ coated fibers in our very efficient pump-oxygenator disc configuration and venovenous cannulation. The increased M-AMMO system efficiency will permit greater gas transfer rates than are currently available and will be compact enough to permit patients to be transferred out of the ICU. Furthermore, if M-AMMO performs as designed it may reduce or preclude the need for mechanical ventilation and its attendant morbidity. This Phase I program is designed to demonstrate the feasibility of our concept. The aims of this program are to modify our current design to meet the needs of the adult patient requiring long-term respiratory support, perform sufficient in vitro and in vivo trials to evaluate system performance and suitability for the intended use, and develop a prototype manual controller. If successful, we believe that this Ension product would gain acceptance by cardiothoracic surgeons and pulmonologists throughout the medical community. PROPOSED COMMERCIAL APPLICATIONS: Approximately 100 applications of adult ECMO are voluntarily reported to the ELSO Registry each year, with many more unreported. A device capable of providing all of the respiratory support for an ambulatory patient could offer a serious alternative to mechanical ventilation, reduce overall costs by allowing patients to be transferred to "step-down" units, and be the forerunner of an artificial lung.